Sat.Apr 20, 2024 - Fri.Apr 26, 2024

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FDA initiative puts AR/VR at heart of home health drive

pharmaphorum

A new FDA initiative is seeing how augmented reality and virtual reality (AR/VR) can make patients’ own homes an integral part of the healthcare system

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Novartis nominates former Bristol Myers CEO Giovanni Caforio as its new chair. Will M&A deals follow?

Fierce Pharma

Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. | Giovanni Caforio, M.D., is lining up a new gig soon after handing all his Bristol Myers Squibb leadership roles in March. The recent Big Pharma CEO, known for steering the $74 billion acquisition of Celgene, has been proposed as the new chair at Novartis for 2025.

Pharma 348
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Pfizer and BioNTech commence legal action against Moderna in UK court

Pharmaceutical Technology

Pfizer and its Germany partner BioNTech have urged London’s High Court to invalidate competitor Moderna's patents over technology instrumental in the Covid-19 vaccines development as the latest phase of a global legal fight that started yesterday (23 April), reported Reuters.

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How Will Walgreens’ Expansion into Specialty Pharmacy Affect the Industry?

MedCity News

Walgreens announced that it is expanding its specialty pharmacy offerings. Experts think that this move could yield several strategic benefits, given the higher profit margins associated with specialty medications compared to traditional drugs. They also think Walgreens’ move could lead to greater competition, consolidation and innovation within the broader pharmacy industry.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt

pharmaphorum

After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product

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Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

Fierce Pharma

After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. | After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on the antibody-drug conjugate Trodelvy. With a busy year ahead across therapeutic areas, CEO Dan O'Day emphasized a "time of focused execution.

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Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines

MedCity News

Regeneron Pharmaceuticals is collaborating with CRISPR technologies startup Mammoth Biosciences to develop in vivo gene-editing therapies. The deal marks the third pharmaceutical industry partnership for Mammoth, which initially focused on developing CRISPR-based diagnostics. The post Regeneron Bets $100M That Mammoth’s CRISPR Tech Can Deliver on Next Wave of Genetic Medicines appeared first on MedCity News.

Medicine 124
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Owlstone secures $6.5M for breath-based diagnostics for infectious disease

pharmaphorum

Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development of breath-based diagnostic solutions to improve outcomes in the developing world.

Medical 108
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Roche's Vabysmo shows no sign of slowdown after Regeneron and Bayer's launch of Eylea HD

Fierce Pharma

It’s been eight months since Regeneron secured approval for a high-dose version of its powerhouse macular degeneration treatment Eylea in the U.S. | How much impact has the approval of high-dose Eylea had on the upward trajectory of Roche’s Vabysmo? Not much, according to sales figures released by Roche.

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Health Canada approves Merck’s KEYTRUDA for gastric cancer treatment

Pharmaceutical Technology

Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery

MedCity News

ImmunityBio therapy Anktiva is now FDA approved for treating patients with non-muscle invasive bladder cancer. The novel immunotherapy works by sparking activity from three types of immune cells. The post FDA Approves Immunotherapy That Can Spare Bladder Cancer Patients From Radical Surgery appeared first on MedCity News.

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LogiPharma Europe 2024: LogiPharma Commercial Director Discusses Themes of the Show

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Nicholas Saraceno, Will Robinson, Commercial Director, LogiPharma, talks themes of this year's event and future plans for the show.

Pharma 101
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Orphan drug market to reach $270B by 2028, led by J&J, Vertex and Roche: Evaluate

Fierce Pharma

The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. | The orphan drug sector has long been clearing growth in the larger pharmaceutical market with booming sales. But thanks to blockbuster meds across wider disease areas and other challenges, the lucrative market may soon slow down for the first time in years.

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EC approves Pfizer’s Emblaveo for multidrug-resistant infections

Pharmaceutical Technology

The European Commission (EC) has granted marketing authorisation for Pfizer’s EMBLAVEO (aztreonam-avibactam), aimed at treating adults with multidrug-resistant infections where treatment options are limited.

Marketing 101
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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Providence Ordered to Pay $200M for ‘Systemic Wage Violations’

MedCity News

More than 33,000 Providence employees filed a class-action complaint against the health system in 2021, alleging that it had been withholding their wages by denying them breaks and rounding down their working hours. Last week, Providence was ordered to pay more than $200 million in damages — a decision that “sends a message to healthcare corporations,” according to an attorney representing the workers.

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With $75m cash injection, SynOx plans ph3 rare tumour trial

pharmaphorum

Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.

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AbbVie's Skyrizi proves a worthy Humira successor with nearly matching sales ahead of potential UC nod

Fierce Pharma

AbbVie’s immunology heirs Skyrizi and Rinvoq are proving booming growth to make up for once-king Humira’s continuous sales slide. | As Humira continues its sales free fall, newer Skyrizi is proving a worthy successor with nearly matching sales ahead of an upcoming FDA decision in ulcerative colitis.

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Avidity Biosciences gets grant for polynucleic acid conjugate for treating FSHD through rna interference

Pharmaceutical Technology

Discover how Avidity Biosciences' patented polynucleic acid molecule conjugate targets the DUX4 gene to combat FSHD. Learn more about this groundbreaking approach in gene therapy.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Johns Hopkins Is Teaming Up With Healthy.io to Improve Diabetic Patients’ Wound Care

MedCity News

Johns Hopkins Hospital teamed up with Healthy.io, a company that offers smartphone-based technology to improve wound care management for diabetic patients. The partners are conducting a 120-person study to measure the impact of the startup’s technology. The post Johns Hopkins Is Teaming Up With Healthy.io to Improve Diabetic Patients’ Wound Care appeared first on MedCity News.

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Novartis names ex-BMS CEO Caforio as chair amid strong Q1

pharmaphorum

Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results

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Day One takes on Novartis with FDA nod for Ojemda in broader common childhood brain tumor use

Fierce Pharma

Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, the newcomer boasts an FDA approval covering a broader patient population. | Another drug is in town for common pediatric brain tumors. Compared with an incumbent offering from Novartis, Day One's newcomer boasts an FDA approval covering a broader patient population.

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BioMarin Pharmaceutical gets grant for treatment of adolescent PKU patients using AVPAL variant

Pharmaceutical Technology

Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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BMI: A Flawed Measure of Health

MedCity News

It’s time we move beyond BMI and adopt a holistic approach to truly gauge health. The post BMI: A Flawed Measure of Health appeared first on MedCity News.

Biopharma 116
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Moderna banks on OpenAI to accelerate mRNA research 

pharmaphorum

In an ambitious move, Moderna has teamed up with OpenAI, the artificial intelligence company behind ChatGPT, to further integrate generative AI (GenAI) across its mRNA drug development and manufacturing operations.

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AstraZeneca CEO says platform deals largely done after M&As in vaccines, radioligand, cell therapy

Fierce Pharma

After AstraZeneca’s recent acquisitions of various technologies across different therapeutic areas, some investors started to wonder if the British pharma is stretching too thin. | After AstraZeneca’s recent acquisitions of various technologies across different therapeutic areas, some investors started to wonder if the British pharma is stretching too thin.

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Vistagen’s on-demand nasal spray could provide a novel option for social anxiety

PharmaVoice

The fast-acting medication is one of a few new approaches being tested for the crippling condition.

Medical 128
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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It’s Time to Give Patients a Seat at the Table

MedCity News

Game-changing advances can be achieved by integrating patient collaboration and priorities into the full span of trial design. The post It’s Time to Give Patients a Seat at the Table appeared first on MedCity News.

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Roche says it has shed 20% of NMEs from its pipeline

pharmaphorum

Roche chief executive Thomas Schinecker said today that one in five of the pharma division’s pipeline of new molecular entities (NMEs) has been culled in the last few months as part of a shift in focus on “high impact” projects.

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Novo Nordisk lands back in Sanders' crosshairs, this time over steep costs of Ozempic and Wegovy

Fierce Pharma

Just a few months after laying into CEOs from Bristol Myers Squibb, Merck & Co., and Johnson & Johnson about the high costs of their drugs, Sen. | Just a few months after laying into CEOs from Bristol Myers Squibb, Merck & Co. and Johnson & Johnson about the high costs of their drugs, Sen. Bernie Sanders, I-Vermont, is taking Novo Nordisk to task for allegedly turning its blockbuster GLP-1s Ozempic and Wegovy into “luxury goods.

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Benefits of 3D printing for personalised medicine formulation

European Pharmaceutical Review

A paper has reported the first time that 3D printing has facilitated two active pharmaceutical ingredients (APIs) to be combined in the same formulation. This method enables the number of administrations of the drug evaluated to be minimised, the researchers found. The authors aimed to evaluate and compare the efficacy and acceptability of chewable 3D printed medicines containing citrulline, isoleucine, and valine alone or in combination.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.